11/20/2009

Cranial Fixation Device Advances Surgeon/Patient Benefits

The NEOS Cranial LOOPTM, the latest product from NEOS Surgery® is the first-ever cranial fixation device made entirely of PEEK-OPTIMA®, the advanced biocompatible polymer from Invibio Biomaterial Solutions. NEOS’ innovative design harnesses PEEK-OPTIMA’s unique combination of mechanical characteristics and performance properties to realize significant surgeon/patient benefits beyond the range of metallic biomaterials. The result of extensive research and development, the Cranial LOOP is a game-changing addition to NEOS’ line of innovative cranial fixation devices.

The instrument-free design is made possible by PEEK-OPTIMA® material characteristics (including high elastic modulus, high tensile strength, and highly radiolucent CT/MRI imaging without scattering or artifacts) and incorporates a self-cutting function for removing the non-implantable part of the device. A fast and easy “pull and tighten” action allows the surgeon to control and feel the fixation; a standard bone flap with three Cranial LOOPs can be fixated in less than a minute. The NEOS Cranial LOOP produces fixation strengths similar to those of other standard metallic, non instrument-free fixation devices. Its unique design and materials allow it to perfectly adapt to the epicranial and subcranial shape and curvature.

According to Lluís Chico, General Manager, NEOS Surgery, PEEK’s high elastic modulus, similar magnitude to that of bone, and high tensile strength were vital to the design, as was the polymer’s versatility.

“We specifically designed the Cranial LOOP to PEEK-OPTIMA’s properties and material characteristics. PEEK-OPTIMA can be injection molded, which was also vital to our design,” Mr. Chico commented.

“PEEK enabled surgeon and patient benefits beyond the range provided by metallic cranial fixation devices. Surgeons can perform the procedure without instrumentation, and in addition, the Cranial LOOP is completely radiolucent – none of these are possible with metallic biomaterials. Benefits to patients include reduced risk of infection, soft tissue damage, and stress shielding or mechanical mismatch between bone and implant, and, because PEEK-OPTIMA is less likely to attach to tissue, revision surgery is easier as well.” he added.

The benefits and efficacy of the Cranial LOOP have been demonstrated by widespread commercial success across Europe. The Cranial LOOP device is CE marked and is already available in: Spain, Germany, France, Austria, Switzerland, Belgium, the Netherlands, Greece and Turkey. It will be soon available in the European Nordic countries: Sweden, Norway, Finland and Denmark and in the main America’s markets.

Formulated to meet exacting in-vivo criteria, PEEK-OPTIMA is a proven biomaterial that provides medical device manufactures and patients with a variety of distinct advantages over other accepted implant materials such as metals, ceramics, and other polymers, including:
• Proven safety, biocompatibility and biostability;
• Stable electrical insulation properties;
• High mechanical toughness;
• High thin film impact strength;
• Compatible with a range of joining technologies;
• Excellent telemetry and communications characteristics;
• Design flexibility and micro injection moulding of minute intricate parts (miniaturisation);
• Superior chemical resistance, oxidation resistance, and thermal dissipation behaviour; and,
• Natural radiolucency and compatibility with radiograph and magnetic resonance imaging.

About Neos Surgery
NEOS SURGERY SL is an innovative and technology-based company born from the cooperation between Neurosurgeons and two private Research centres: INASMET-TECNALIA Foundation and ASCAMM Foundation. NEOS creates, develops, produces and commercialises implantable neurosurgical devices, and creates new solutions fusing new technologies and innovative materials. Therefore, its implants are: easy-to-use, instrument-free, customised, self-closing, radiolucent, etc.

Nowadays, NEOS is commercialising its instrument-free implants for Cranial Closure (Brain surgery). NEOS’ following products for Brain surgery will be based on the LOOP concept, widening its scope of applications. In the mid term, NEOS will launch new implantable solutions in the field of Spinal surgery following the same innovative philosophy.

NEOS is a certified producer of medical devices and implements the complete ISO 9001-2000 and ISO 13485-2003/AC:2007 quality systems. NEOS recently closed an important investment round with Kutxa-Sendogi Capital FCR, a Venture Capital fund managed by TALDE Gestión SA.

For more information, please contact NEOS Surgery at: +34 935 944 726 (Barcelona, Spain), at info@neosurgery.com or online at www.neosurgery.com.

About Invibio
Invibio® is a global leader providing high performance biomaterials, advanced technical research and consultative solutions to medical device manufacturers across a wide range of markets. The company provides medical device manufacturers with PEEK-OPTIMA® polymer and compounds, MOTIS™ polymer, ENDOLIGN™ composite and PEEK-CLASSIX™ polymer for the development of long- and short-term implantable medical devices.